Manufacturing processes, from the receipt of raw materials to packaging and distribution, are subject to strict standards. The purpose of packaging validation is to ensure that the right product is packaged and that the packaging process is consistently reproducible. Several factors must be taken into account when validating a pharmaceutical packaging process, including:
- the type of product being packaged;
- the packaging materials and components;
- the packaging equipment;
- the environment in which packaging takes place.
MGA Technologies designs custom machines for pharmaceutical packaging inspection. MGA Technologies designs custom machines for inspection, testing and identification for this type of need.
Guaranteeing the Conformity of Sealed Pharmaceutical Packaging
The conditions for validating pharmaceutical packaging are set out in European Directive 2011/62/EU (falsified medicines) and in EN 16679, the European standard on tamper verification features for medicinal product packaging. These texts propose several packaging solutions, such as gluing, plastic film packaging, special folding techniques and the use of adhesive films.
In particular, Directive 2011/62/EU requires that:
- The design of the packaging must be validated to ensure that it is suitable for its intended use;
- The manufacturing process must be validated to ensure that the packaging is produced consistently and to the required quality standards;
- The packaging must undergo periodic inspection and testing to ensure that it remains fit for purpose.
In addition, good manufacturing practice (GMP) for medicinal products requires that all materials and components used to manufacture pharmaceutical packaging meet the following criteria:
- They must be of the correct type and quality;
- They must be suitable for their intended use;
- They must be suitable for the manufacturing process;
- They must be stored and used in a way that protects them from contamination and degradation.
Advanced Vision and Multi-Criteria Detection for Flawless Compliance
Packaging inspection leaves no room for approximation in the pharmaceutical industry. Modern advanced vision solutions reach a very high level of precision and can identify defects invisible to the naked eye. With multi-criteria detection, each package is examined against several parameters, including mechanical integrity, surface cleanliness, marking legibility and seal conformity. This comprehensive approach detects the slightest non-conformity, whether micro-cracks, unwanted particles or faulty printing. Inspection works hand in hand with pharmaceutical packaging labeling and coding.
High-resolution optical systems coupled with smart algorithms provide fast, reliable processing that keeps up with demanding industrial throughputs. These technologies do more than identify anomalies: they also help improve processes by providing usable data in real time. Advanced vision and multi-criteria detection have thus become essential allies for securing batch quality and strengthening the confidence of patients and authorities.
Industry 4.0 Technologies for Custom Pharmaceutical Inspection
Pharmaceutical packaging inspection is now moving into an Industry 4.0 dimension, with mechatronics and software intelligence at the heart of the equipment. These custom machines combine high-precision mechanical design, advanced automation and dedicated software to deliver efficient, adaptable inspection. They include automated tests such as vision, leak detection or micro-defect inspection, all within a connected, scalable environment.
With the industrial IoT, every check is traced, archived and used in real time, which strengthens traceability and meets the growing expectations of authorities in terms of compliance and transparency. This smart integration also supports energy efficiency and resource optimization, in line with environmental and sustainability goals. Inspection solutions thus become not only guarantors of pharmaceutical quality but also tools for continuous improvement, and they can be integrated into a complete pharmaceutical packaging line.
MGA, Designer of Custom Machines for Validating Pharmaceutical Packaging
MGA Technologies has developed solutions for the inspection of pharmaceutical packaging. High-performance and innovative, the equipment we offer ensures the conformity of pharmaceutical packaging. See, for example, our automatic pharma kit preparation line.
The machines we design guarantee the integrity of your products. They detect any form of packaging anomaly, such as damaged corners, tears, protruding tabs, poor seals or oil stains.
MGA Technologies’ pharmaceutical packaging inspection machines incorporate sophisticated vision algorithms. They are able to detect, capture and classify complex defects, such as insufficient or broken seals. They detect not only aesthetic defects but also dimensional defects in packaging and overwrapping. Inspection is carried out at a very high rate and respects the sterility of the product. The machines can also incorporate leak-testing equipment to guarantee physical compliance in addition to visual compliance, so that product sterility is maintained.
MGA, a Supplier of Machines for Industry 4.0
MGA Technologies is a French company specializing in the design and manufacture of special, made-to-measure machines for Industry 4.0. MGA Technologies anticipates technological trends and integrates ecological and human issues to achieve sustainable gains in competitiveness.
Always attentive to our customers’ needs and their product and process constraints, we design and build your machines and equipment to help you move toward the industry of the future. Constantly monitoring innovative mechatronic and digital technologies, our teams guide you in your choices to meet your needs. To learn more, see our custom secondary packaging machines.
If you have any questions, don’t hesitate to contact us. Our experts are on hand to provide you with a rapid, personalized response.
